The information provided by the firm is adequate to support the proposed change. I recommend that an email be sent to the applicant indicating they may distribute the device incorporating the change as requested in this supplement. This change applies to the final assembly of the superion™ indirect decompression system (ids) device as described in p140004/s025. The following manufacturing facility is affected by the change: boston scientific limitedcashel rdclonmelcotipperaryireland
| Device | Superion™ Indirect Decompression System (IDS) |
| Generic Name | Prosthesis, Spinous Process Spacer/plate |
| Applicant | Boston Scientific Neuromodulation |
| Date Received | 2021-07-30 |
| Decision Date | 2021-08-26 |
| PMA | P140004 |
| Supplement | S025 |
| Product Code | NQO |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Neuromodulation 25155 Rye Canyon Loop valencia, CA 91355 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P140004 | | Original Filing |
| S029 |
2022-12-08 |
30-day Notice |
| S028 |
2021-12-03 |
Real-time Process |
| S027 |
2021-12-03 |
Normal 180 Day Track No User Fee |
| S026 |
2021-09-07 |
30-day Notice |
| S025 |
2021-07-30 |
30-day Notice |
| S024 |
2020-08-24 |
Normal 180 Day Track No User Fee |
| S023 |
2020-08-24 |
30-day Notice |
| S022 | | |
| S021 |
2020-08-24 |
30-day Notice |
| S020 | | |
| S019 |
2020-07-20 |
30-day Notice |
| S018 |
2020-06-17 |
Real-time Process |
| S017 |
2020-05-13 |
Normal 180 Day Track No User Fee |
| S016 |
2019-10-08 |
Real-time Process |
| S015 |
2018-06-22 |
Normal 180 Day Track |
| S014 | | |
| S013 |
2018-03-23 |
30-day Notice |
| S012 |
2017-12-15 |
Normal 180 Day Track No User Fee |
| S011 |
2017-11-27 |
Normal 180 Day Track No User Fee |
| S010 |
2017-11-16 |
Normal 180 Day Track No User Fee |
| S009 |
2017-08-28 |
Normal 180 Day Track No User Fee |
| S008 |
2017-02-21 |
Normal 180 Day Track No User Fee |
| S007 |
2017-01-13 |
Normal 180 Day Track No User Fee |
| S006 |
2017-01-05 |
Normal 180 Day Track No User Fee |
| S005 |
2017-01-05 |
Normal 180 Day Track |
| S004 |
2016-07-25 |
Normal 180 Day Track |
| S003 |
2015-08-13 |
135 Review Track For 30-day Notice |
| S002 |
2015-06-22 |
Normal 180 Day Track No User Fee |
| S001 |
2015-06-22 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices